U.S. patent application number 15/940138 was filed with the patent office on 2018-08-02 for cutaneous field stimulation with disposable and rechargeable components.
The applicant listed for this patent is Meagan Medical, Inc.. Invention is credited to William J. Carroll, William R. Huseby, Mark E. Schoening, Patrick A. Scranton.
Application Number | 20180214693 15/940138 |
Document ID | / |
Family ID | 51351791 |
Filed Date | 2018-08-02 |
United States Patent
Application |
20180214693 |
Kind Code |
A1 |
Carroll; William J. ; et
al. |
August 2, 2018 |
Cutaneous Field Stimulation with Disposable and Rechargeable
Components
Abstract
A CFS system includes self-adhesive, disposable pads. Each pad
is combined with a sealed, cleanable battery/controller pod and
then placed on the body where needed. The battery/controller pod
preferably has wireless capability, such as Bluetooth.RTM.
capability. The patient can download an application to a smartphone
or similar mobile device to control the pods.
Inventors: |
Carroll; William J.;
(LaCenter, WA) ; Schoening; Mark E.; (Portland,
OR) ; Scranton; Patrick A.; (Vancouver, WA) ;
Huseby; William R.; (Vancouver, WA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Meagan Medical, Inc. |
Vancouver |
WA |
US |
|
|
Family ID: |
51351791 |
Appl. No.: |
15/940138 |
Filed: |
March 29, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14181004 |
Feb 14, 2014 |
9962546 |
|
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15940138 |
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61767509 |
Feb 21, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/36021 20130101;
A61N 1/0476 20130101; A61N 1/0456 20130101; A61N 1/0492 20130101;
A61N 1/3603 20170801 |
International
Class: |
A61N 1/36 20060101
A61N001/36; A61N 1/04 20060101 A61N001/04 |
Claims
1. A method for cutaneous field stimulation, the method comprising:
(a) providing: a processing device; a plurality of sealed and
cleanable battery/controller pods, each of the pods being
configured for wireless communication with the processing device;
and a plurality of disposable pads that are configured such that
each pod is insertable into a pocket of one of the pads, each of
the pads comprising TENS pads and CFS needle electrodes, wherein
the TENS pads generally surround the pocket of the pad, wherein
each pad has circuitry on a substrate for conveying power from the
pod to the TENS pads and the CFS needle electrodes, and the
circuitry of each pad extends through the pocket to engage the pod;
wherein the processing device is configured to control the pods
over the wireless communication to implement the cutaneous field
stimulation; (b) determining locations on a patient's body where
the cutaneous field stimulation is needed; (c) selecting a set of
the pads to place on the locations determined in step (b); (d)
inserting one of the pods into each of the pads selected in step
(c); (e) placing the pads selected in step (c) with the pods
inserted in step (d) onto the locations determined in step (b); and
(f) controlling the pods placed in step (e) with the processing
device to apply the cutaneous field stimulation through the
pads.
2. The method of claim 1, wherein each of the pods provided in step
(a) comprises: a battery; a microcontroller; and a communication
device for wireless communication between the microcontroller and
the processing device.
3. The method of claim 1, wherein step (a) further comprises
providing a charger for the pods.
4. The method of claim 3, wherein the charger comprises a component
for disinfecting the pod while charging the pod.
5. The method of claim 1, wherein step (f) comprises: (i) running
an application on the processing device, the application providing
a graphical user interface; and (ii) inputting the locations
determined in step (b) into the processing device through the
graphical user interface.
6. The method of claim 5, wherein step (f) further comprises: (iii)
selecting treatment programs to be applied to the locations
determined in step (b), using the graphical user interface.
7. The method of claim 6, wherein step (f)(iii) comprises selecting
different ones of the treatment programs for different ones of the
locations.
8. The method of claim 1, further comprising, after step (f): (g)
removing the pads and the pods from the locations; (h) removing the
pods from the pads; and (i) disposing of the pads.
9. The method of claim 8, further comprising, after step (h): (j)
recharging the pods.
10. The method of claim 8, further comprising, after step (h): (k)
disinfecting the pods.
11. The method of claim 8, further comprising, after step (h): (j)
recharging the pods; and (k) disinfecting the pods, wherein steps
(j) and (k) are performed concurrently, using a charging and
disinfecting device.
12. A method for cutaneous field stimulation, the method
comprising: inserting a battery/controller pod in a disposable pad
that is configured such that the pod is insertable into a pocket of
the pad, the pad comprising a TENS pads that generally surround the
pocket and CFS needle electrodes, and the pad has circuitry on a
substrate for conveying power from the pod to the TENS pads and the
CFS needle electrodes, and the circuitry extends through the pocket
to engage the pod; and applying the pod and the pad to a part of a
patient's body where the cutaneous field stimulation is
desired.
13. The method of claim 12, further comprising a processing device
in wireless communication with the pods controlling the pods to
apply the cutaneous field stimulation through the pads.
14. The method of claim 12, wherein the pod comprises a battery and
a microcontroller.
15. The method of claim 14, wherein the pod further comprises a
communication device for wireless communication between the
microcontroller and an external device.
16. The method of claim 12, further comprising: (d) providing a
charger for the pod; and (e) charging the pod, using the
charger.
17. The method of claim 16, wherein the charger comprises a
component for disinfecting the pod while charging the pod, and the
method further comprises (f) disinfecting the pod, using the
charger.
18. The method of claim 17, wherein steps (e) and (f) are performed
concurrently.
19. A method for cutaneous field stimulation, the method
comprising: running an application, by a processing device, the
application providing a graphical user interface indicating
locations on a patient's body where the cutaneous field stimulation
is to be applied using pads; receiving, by the graphical user
interface, a selection of a treatment program to be applied to the
locations on the patient's body; and controlling, by the processing
device being in wireless communication with pods insertable into
the pads, the pods to apply the cutaneous field stimulation through
the pads, wherein the pods are insertable into a respective pocket
of a respective pad, each pad comprising a TENS pad that generally
surrounds the pocket and CFS needle electrodes, and each pad having
circuitry on a substrate for conveying power from the pod to the
TENS pads and the CFS needle electrodes, and the circuitry extends
through the pocket to engage the pod.
20. The method of claim 19, further comprising: concurrently, using
a charging and disinfecting device, recharging the pods and
disinfecting the pods.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] The present disclosure is a divisional of and claims
priority to U.S. patent application Ser. No. 14/181,004, filed on
Feb. 14, 2014, which claims the benefit of U.S. Provisional Patent
Application No. 61/767,509, filed Feb. 21, 2013, each of which is
incorporated by reference in its entirety. Related subject matter
is disclosed in U.S. Patent Application Publication No.
2010/0274327 A1 and in U.S. Pat. Nos. 8,086,322 and 8,386,005. The
disclosures of all of the above applications and patents are hereby
incorporated by reference in their entireties into the present
disclosure.
FIELD OF THE INVENTION
[0002] The present invention is directed to cutaneous field
stimulation and more particularly to such stimulation with
disposable and rechargeable components.
DESCRIPTION OF RELATED ART
[0003] Electroanalgesic therapies are known nonpharmacologic
alternatives to conventional analgesic drugs for the management of
acute and chronic pain. For example, percutaneous electrical nerve
stimulation (PENS) is a known form of electroanalgesic therapy
typically used for the treatment of intractable pain associated
with chronic low back pain syndrome by stimulating the spinal cord
(SCS) using electrodes implanted percutaneously into the epidural
space as a trial before a more permanent total implantation of an
SCS System. The term PENS has also been used to describe a
technique for inserting 32-gauge acupuncture needles into soft
tissues or muscles to electrically stimulate peripheral nerve
fibers in the sclerotomal, myotomal, or dermatomal distribution
corresponding to a patient's pain symptoms. Medical devices having
arrays of percutaneous electrodes that utilize microstructure
needles, which are less invasive than deeper-penetrating
acupuncture needles, have also been used for delivering PENS. The
microstructure needles provide sufficient penetration to overcome
the electrical impedance of the skin tissue for effectively
recruiting sensory fibers.
[0004] As the understanding of the topographical organization of
nociceptive systems becomes more detailed, the target location of
the stimulation, the percutaneous electrodes' depth of penetration,
and the current amplitude become more exacting. Percutaneous
neuromodulation therapy (PNT) and cutaneous field stimulation (CFS)
are specific forms of PENS that have been developed using that
understanding. PNT is used for the treatment of cervical and lumbar
pain and utilizes longer, acupuncture-type needles having a depth
of penetration into the skin tissue of up to 3 cm. CFS is used more
generally to treat pain and itch and utilizes an array of
microstructure needles introduced close to the nerve endings in the
skin. Because of the stringent requirements established for needle
electrodes by the Food and Drug Administration (FDA) regarding the
packaging, sterilization, reuse, and disposal of such electrodes,
treatments utilizing such electrodes have generally been
administered under the supervision of a physician (e.g., in a
doctor's office or a clinic).
[0005] CFS is used to assist in the management of chronic
nociceptive and neuropathic pain based on the understanding that
specific types of sensory nerves that are linked to diminishing the
perception of pain can be activated by low amplitude, long duration
electrical stimulation if electrodes having sharp tips (i.e.,
microstructure needles) are introduced close to the nerve endings
in the skin. CFS treatment also influences specific active
components necessary for perceiving itch by inducing long lasting
inhibitory mechanisms in central pathways and by actually
normalizing the number of epidermal sensory fibers in itchy skin.
Accordingly, CFS also provides an alternative to known treatments
for localized itch.
[0006] The sensory receptors stimulated by CFS are axons within the
skin tissue known as nociceptors, specifically A.delta. and C nerve
fibers. The stimulation of A.delta. and C nerve fibers, although
effective in diminishing the perceptions of both pain and itch, can
be a relatively uncomfortable treatment because a prickling and/or
burning sensation is perceived from the stimulation of the A.delta.
and C nerve fibers, which can be uncomfortable and painful. Because
the aversiveness of A.delta. and C nerve fiber stimulation can be
masked by A.beta. fiber stimulation, it would be a considerable
advantage to combine A.beta. fiber stimulation (e.g.,
transcutaneous electrical nerve stimulation (TENS)) and A.delta.
and C fiber stimulation (e.g., CFS) in the same equipment.
Accordingly, there is a need for a method and device that combines
A.beta. fiber stimulation and A.delta. and C fiber stimulation in
one treatment. Moreover, there is a need for a method and device
that combines TENS and CFS in one treatment.
[0007] Cutaneous Field Stimulation (CFS) is a technique for
relieving itch and pain that allows topographically restricted and
tolerable electrical stimulation of thin (A.delta. and C) cutaneous
fibers but is not well suited for the stimulation of A.beta.
fibers. CFS uses a flexible plate with multi-array needle-like
electrodes regularly fixed at 2-cm intervals. Each electrode is
surrounded by an elevated "stop-device" about 2.0 mm in diameter
that protrudes 2.0 mm from the plate. The electrode tip usually
protrudes 0.3 mm to 0.4 mm from the stop-device. When gently
pressing the electrode plate against the skin, the electrode tips
are introduced close to the receptors in the epidermis and the
superficial part of dermis. Since the electrodes traverse the
electrically isolating horny layer of the epidermis and the current
density is high near the sharp electrode tips, the voltage and
current required for stimulating cutaneous nerve fibers are small,
typically less than 50 V and up to 2 mA, respectively. As the
current density decreases rapidly with distance, localized
stimulation is achieved. The electrodes are stimulated
consecutively with a constant current stimulator, each electrode
with a frequency of 1-10 Hz (pulse duration 1.0 ms) and treatment
duration of 5-45 min. In its original embodiment, a self-adhesive
surface (TENS) electrode served as anode and was usually placed
about 5-30 cm away from the needle electrode plate.
[0008] Recent improvements in CFS are taught, e.g., in U.S. Pat.
No. 8,086,322. However, it would be helpful to provide a CFS system
that is less expensive and more easily used than present
systems.
[0009] CFS works best on pain or itch that is focused in one main
area. Therefore, one of the challenges of using CFS for itch or
pain that is not focused in one particular area is the distribution
of the signal. CFS is most effective when placed directly over the
area of pain or itch. Therefore, pain or itch that is distributed
over multiple areas requires repeated use of the stimulator
serially in each zone of pain or itch. Having a system that would
allow simultaneous stimulation of multiple sites with an easy to
use interface would be advantageous.
SUMMARY OF THE INVENTION
[0010] It is therefore an object of the invention, in at least some
embodiments, to provide a system using less expensive pads.
[0011] It is another object of the invention, in at least some
embodiments, to provide such a system that is easier and more
convenient for the patient to use.
[0012] It is still another object of the invention, in at least
some embodiments, to provide such a system that uses, as its
controller, a device that the patient will likely already own, such
as a smartphone.
[0013] To achieve the above and other objects, the present
invention, in at least some embodiments, is directed to a CFS
system having self-adhesive, disposable pads. Each pad is combined
with a sealed, cleanable battery/controller pod and then placed on
the body where needed.
[0014] The battery/controller pod preferably has wireless
capability, such as Bluetooth.RTM. capability. The patient can
download an application to a smartphone or similar mobile device
(e.g., iPhone, iPad, or Android smartphone). The application guides
the patient in the placement of the pads and then controls the
smartphone or other mobile device to connect with the
battery/controller pods wirelessly and to act as a central
controller for the battery/controller pods. The use of that
application allows both easy upgradability and a user-friendly
graphical user interface and also makes use of a device that the
patient likely already has and with which the patient is
familiar.
[0015] The patient is also provided with an inductive charger for
the battery/controller pods.
[0016] The inductive charger can also have cleaning capability.
Once the treatment is over, the patient discards the pads and
places the pods into the charger.
[0017] A CFS system that has multiple channels with a fewer number
of needle like (NL) electrodes per electrode plate (4 to 6 instead
of 14 to 16) could be tailored to more effectively treat each zone
of pain or itch by titrating the level of stimulation or amplitude
for each channel or zone. The size of the treatment zone could also
be increased or decreased by adding multiple disposable electrode
plates to match the size of the pain or itch zone. The level of
stimulation or amplitude of each electrode plate could be
individually adjusted and tuned to provide the optimal amount
needed at each zone. Using a remote controller (e.g., a smartphone)
to adjust the output and parameters of each zone and connecting the
controller with each of the electrode plates using Bluetooth or
other wireless technology would greatly increase the convenience
and ease of use of the CFS system. This type of CFS system would
provide a more effective and easier to use treatment of pain and
itch due to its scalability, convenience and adjustability.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] A preferred embodiment of the present invention will be set
forth in detail with reference to the drawings, in which:
[0019] FIG. 1 is a drawing showing the configuration of a pad;
[0020] FIG. 2 is a drawing showing a retail package in which the
pads are sold to the patient;
[0021] FIG. 3 is a drawing showing the way in which the pad and the
pod are combined for use;
[0022] FIG. 4 is a schematic diagram showing the circuitry in the
pod of FIG. 3;
[0023] FIG. 5 is a drawing showing the way in which the pods are
placed into the charger after use;
[0024] FIG. 6 is a drawing showing the smartphone running the CFS
application, the communication between the mobile device and the
pads, and the placement of the pads on the patient's body;
[0025] FIGS. 7A through 7L are diagrams showing steps in the use of
the CFS system;
[0026] FIG. 8 is a drawing showing a possible modification of the
pads;
[0027] FIG. 9 is a drawing showing one possible configuration for
the charger;
[0028] FIG. 10A is a perspective view showing another possible
configuration for the charger;
[0029] FIG. 10B is a cross-sectional view taken along lines XB-XB
of FIG. 10A; and
[0030] FIG. 11 is a drawing showing another possible modification
of the pads.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0031] A preferred embodiment of the present invention and
variations thereof will be set forth in detail with reference to
the drawings, in which like reference numerals refer to like
elements or steps throughout.
[0032] FIG. 1 shows a pad 100 according to the preferred
embodiment. The pad 100 includes a substrate 102 carrying a
flexible circuit 104, TENS pads 106, and CFS blades 108. An
adhesive 110 is applied to allow adhesion to the patient's skin,
and a cover 112 (not shown in FIG. 1, but shown in FIG. 7B) is
disposed on the pad 100. The flexible circuit 104 has a portion 114
formed in a pocket 116 in the substrate 102 to receive power from a
pod (to be described below).
[0033] The pad 100 is consumable, disposable, and self-adhesive. It
has a flexible circuit, one-use gel pads, and one-use CFS
blades.
[0034] FIG. 2 shows multiple pads 100 in an over-the-counter
consumer 12-pack 200 having a sheet 202 and an envelope 204. Of
course, the pads 100 could be packaged singly or in any number, and
the configuration of the packaging can be changed as desired as
long as the pads 100 are adequately protected.
[0035] FIG. 3 shows a pod 300 for use with the pad 100. The pod 300
is reusable and rechargeable and is inserted into the pocket 116 of
the pad 100. The pod 300 can have a surface antimicrobial treatment
to assure cleanliness and decrease any possibility of
contamination. In addition, or instead, a disinfecting device, to
be described below, can be used, or the pods can be wiped with
disinfecting cloths between uses.
[0036] FIG. 4 is a circuit diagram showing the circuitry contained
in the pod 300. The pod 300 contains a 3V battery 402 and output
circuitry 404 for providing a 50V output. The battery 402 has a
life of 20 minutes and operates under control of a microelectronic
controller 406 and a Bluetooth communication device 408. Of course,
any suitable values and any suitable communication protocol could
be used instead.
[0037] FIG. 5 shows an inductive pod charger 500 into which
multiple pods 300 are inserted for inductive charging.
[0038] FIG. 6 shows multiple pads 100 placed on the back of a
patient P. A suitably programmed smartphone or other wireless
device 600 communicates with the pods (not shown in FIG. 6) using a
Bluetooth connection 602.
[0039] FIGS. 7A through 7L show steps in the use of the preferred
embodiment. In FIG. 7A, the patient P is suffering from lower-back
and shoulder pain. In FIG. 7B, the patient P peels off the cover
112 from the pad 100 and inserts a battery/controller pod 300. In
FIG. 7C, the patient P places a pad, with the pod inserted, at each
pain zone. In FIG. 7D, the patient P runs the smartphone
application on the smartphone 600 and selects the transducer
locations on the application's graphical user interface 702. The
application can also prompt the patient on where to place the pads
using diagrams or photographs taken by the doctor at the initial
appointment. Of course, the order of performing the steps of FIGS.
7B-7C and the step of FIG. 7D could be reversed. In FIG. 7E, the
patient P chooses a treatment program for each zone on the
graphical user interface 702. The programs can be custom designed
by the user and saved and named if liked, or the doctor can set and
lock each program. In FIG. 7F, the patient P presses the "Start
Treatment" button 704 on the graphical user interface 702. The
graphical user interface 702 can show intensity, program curves,
and the like. The application can also play music or video or allow
the patient to play a game. In FIG. 7G, the pods 300 and the
smartphone 600 communicate wirelessly over the Bluetooth connection
602 to control each pod 300 to load and start the appropriate
treatment to the zone where it is located. In FIG. 7H, the
treatment programs are running, and the patient P can relax during
treatment. In FIG. 7I, the treatment programs are finished, and the
patient P removes each pad 100 and removes each pod 300 from its
corresponding pad. In FIG. 7J, each pad, which is intended for a
single use, is discarded. In FIG. 7K, the pods 300 are placed into
an inductive charger 500. In FIG. 7L, the process ends, and the
patient's pain is relieved.
[0040] The application can wirelessly transmit information after
each treatment to the doctor for the patient's file. The details
can include duration, program setting, date and time. The
application can also provide regular reminders to help the patient
tailor and follow treatment guidelines as fits the patient's
schedule. Communication with the doctor's office can be by any
suitable communication technology, e.g., the data connection or SMS
functionality in the smartphone 600.
[0041] The use of a smartphone or tablet means less physical
product to track, produce, repair, or update, since the application
can be implemented on hardware that the patient likely already has.
Alternatively, a dedicated device can be produced. Product updates
can largely be done by releasing updates of the application. Such
updates can upgrade the look/feel and performance of the user
interface and the programs.
[0042] The product will conform to the patient's aesthetics because
the patient has already chosen the device and the cover. The user
interface can also include options to customize such things as the
color schemes.
[0043] Small, independent transducers (pad/pod combinations) make
placement, coverage, and focus easier. In a variation of the
preferred embodiment, shown in FIG. 8, changeable color-coded rings
800 provide a visual reference for placement and program options in
the user interface.
[0044] FIG. 9 shows an example of an inductive charging pad 500.
The charging pad 500 has a dimple 902 into which each pod 300 can
be snapped for charging. Some sort of contact charging can be
provided instead.
[0045] FIGS. 10A and 10B are a perspective view and a
cross-sectional view, respectively, of a charging box 1000 that
charges one side and disinfects the other side simultaneously. The
box 1000 includes an inductive charging mat 1002 and a capillary
foam 1004 for applying a sterilization fluid 1006 to the pod
300.
[0046] FIG. 11 shows multiple sheets 1100 to keep different colored
transducers 1102 separate. This can be useful if, for example,
different types of transducers are provided.
[0047] While a preferred embodiment and variations thereon have
been set forth in detail above, those skilled in the art who have
reviewed the present disclosure will readily appreciate that other
embodiments can be realized within the scope of the invention. For
example, numerical values are illustrative rather than limiting, as
are disclosures of specific technologies, technical standards, and
methods of charging the pods. Therefore, the present invention
should be construed as limited only by the appended claims.
* * * * *